UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000025482 |
|---|---|
| Receipt number | R000029327 |
| Scientific Title | The effects of foot drop stimulator controlled by a tilt sensor combined with integrated volitional control electrical stimulation on gait performance in stroke patients |
| Date of disclosure of the study information | 2017/01/04 |
| Last modified on | 2018/07/08 11:38:37 |
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Basic information
Public title
The effects of foot drop stimulator controlled by a tilt sensor combined with integrated volitional control electrical stimulation on gait performance in stroke patients
Acronym
The effects of foot drop stimulator controlled combined with integrated volitional control electrical stimulation in stroke patients
Scientific Title
The effects of foot drop stimulator controlled by a tilt sensor combined with integrated volitional control electrical stimulation on gait performance in stroke patients
Scientific Title:Acronym
The effects of foot drop stimulator controlled combined with integrated volitional control electrical stimulation in stroke patients
Region
| Japan |
Condition
Condition
stroke
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate whether or not foot drop stimulator controlled combined with integrated volitional control electrical stimulation would improve gait performance of patients with post-stroke
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Root mean squares of trunk acceleration during walking
Key secondary outcomes
fugl-meyer assessment (the lower extremity), stroke impairment assessment set (foot-pat test), modified ashworth scale
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Foot drop stimulator controlled combined with integrated volitional control electrical stimulation in addition to usual rehabilitation program
Interventions/Control_2
Integrated volitional control electrical stimulation in addition to usual rehabilitation program
Interventions/Control_3
Usual rehabilitation program alone
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Consent to participate in the study
2) First-time stroke with a duration of less than 6 months from the onset of stroke
3) The ability to walk without support for at least 30-meters
4) The score of SIAS foot-pat test is 1 or more.
5) Capability of communicating and understanding instructions
Key exclusion criteria
1) Contraindications for electrical stimulation
2) Severe sensory deficits
3) Neurological condition unrelated to stroke hemiparesis
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Tsubasa Mitsutake |
Organization
Shiroishi Kyoritsu Hospital
Division name
Department of Rehabilitation
Zip code
Address
1296 Fukuta, Shiroishi-cho, Kishima-gun, Saga
TEL
0952-84-6060
mitutuba1012@gmail.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Tsubasa Mitsutake |
Organization
Shiroishi Kyoritsu Hospital
Division name
Department of Rehabilitation
Zip code
Address
1296 Fukuta, Shiroishi-cho, Kishima-gun, Saga
TEL
0952-84-6060
Homepage URL
mitutuba1012@gmail.com
Sponsor or person
Institute
Shiroishi Kyoritsu Hospital
Institute
Department
Personal name
Funding Source
Organization
nothing
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
白石共立病院（佐賀県）
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 01 | Month | 04 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2017 | Year | 01 | Month | 04 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 01 | Month | 11 | Day |
Last follow-up date
| 2018 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2018 | Year | 07 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2016 | Year | 12 | Month | 30 | Day |
Last modified on
| 2018 | Year | 07 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029327
